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To built a dry eye acupoint therapeutic instrument by stimulating acupoints with low impulse current .And the safety of the dry eye acupoint treatment device will be tested and the initial validation will be verified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry eye acupoint therapy instrument treatment group One | Experimental | Dry eye acupoint therapy instrument treatment group One was treated with instrument twice a week, at least two day apart, each time lasting 30 minutes. Treatment points include Jingming, Cunzhu, Si Zhukong , Sun , Sibai and Chengqi. |
|
| Dry eye acupoint therapy instrument treatment group Two | Experimental | Dry eye acupoint therapy instrument treatment group Two had the same treatment method with different treatment parameters. |
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| Artificial tear treatment group | Active Comparator | The artificial tear treatment group was treated with artificial tear (Ali eye drops) four times a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dry eye acupoint therapy instrument | Device | The dry eye acupuncture point treatment device treat dry eye through stimulating acupuncture points by low pulse current. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Schirmer's test (SLT) | The Schirmer test uses filter paper to wick up tears and measure the amount of production. | baseline and 8 weeks post-treatment |
| Tear film breakup time (TBUT) | The time interval between keeping eyes open after blinking until the first dry spot appears on the tear film surface is one of the important criteria to evaluate the stability of tear film. | baseline and 8 weeks post-treatment |
| Ocular Surface Disease Index, OSDI | The most commonly used questionnaire in clinical diagnosis of dry eye. It is mainly used to diagnose dry eye and assess the severity of the condition | baseline and 8 weeks post-treatment |
| Corneal fluorescein staining (CFS) | Corneal fluorescein staining (CFS) is a valuable clinical tool to assess the viability of the epithelium. | baseline and 8 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| MGD | Meibomian Gland (MG) expressibility and secretion quality | baseline and 8 weeks post-treatment |
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Inclusion Criteria:
Those who met the above criteria could be included in the study.
Exclusion Criteria:
(9)Patients with serious life-threatening primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system diseases, as well as mental illness; (10)Attending other clinical trials.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tenth People's Hospital | Shanghai | Shanghai Municipality | 270002 | China |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Artificial tear | Drug | 0.3% Ali eye drops |
|
| D045506 |
| Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |